Action 27. Mobilize their networks and work with communities to help build treatment literacy, generate demand, and expand access to ARVs among children.
Action 34. Increase efforts to share information on the roll-out of new paediatric formulations, including lessons learned.
Paediatric HIV & TB : Rome Action Plan
1. Scale up appropriate, timely, high quality, cost-effective early infant diagnosis, using comprehensive laboratory mapping and optimized use of all available diagnostic resources, recognizing the patient benefits of Point of Care (POC) Early Infant Diagnosis (EID) for timely diagnosis and ART initiation.
2. Prioritize effective, evidence-based case-finding strategies to increase demand for testing of children of all ages and improve patient identification, including testing all children attending nutrition, TB, and inpatient wards, testing of mother-infant pairs in immunization clinics, scaling up index testing, etc.
3. Develop strategies to optimize the use of new technologies and interventions in countries.
4. Work with national regulatory authorities to streamline procedures and strengthen the use of WHO prequalification listing when considering national regulatory approval.
5. Develop more accurate, transparent, and consolidated forecasts to support manufacturing and reagent availability.
6. Support multiplexing of available diagnostic technologies across programs for more optimal utilization of available platforms and wider access to testing.
7. Work towards eliminating user fees from diagnostic and health services in the public sector.
8. Prioritize fast track national regulatory approval of EID and viral load (VL) products that have stringent international regulatory approval and/or WHO prequalification listing.
9. Accept WHO guidance suggesting countries should refrain from requiring national evaluation studies that would be duplicative, but instead adopt a rapid and streamlined registration and national approval process for EID and viral load products.
10. Prioritize the development and operationalization of collaborative regional registration schemes and take part in the collaborative registration procedure for diagnostics, to be developed by the WHO.
11. Develop and implement post market surveillance of diagnostic products.
Kenya has not found secured funding for POC EIDs. Kenya is still looking for resources to scale up EID POC.
The program is planning to review the ARV guidelines to incorporate ARV optimisation for children and adolescents living with HIV. This will enable scale up of new regimes as they become available.
1. Adopt and implement WHO TB guidelines as relevant for infants and children in case-finding, screening, and testing.
2. Scale up available, appropriate, timely, quality assured pediatric TB diagnostics, using comprehensive diagnostic network mapping and optimized use of all diagnostic resources to maximise paediatric case detection.
3. Ensure follow-up, screening and appropriate care for children who are a household contact of a person living with TB, and that pediatric case-finding is prioritized.
4. Implement rapid molecular assays for detection of TB in infants and children, including use of stool and other non-sputum specimens endorsed by WHO.
5. Implement the TB-LAM assay and/or similar urine-based lateral flow assays for routine use in both TB and HIV national programs in line with the latest WHO recommendations to support identification of TB in all HIV-infected infants and children.
6. Incorporate costed and budgeted requests for interventions for pediatric TB diagnosis, including procurement, training, and case-finding interventions, into Global Fund and PEPFAR requests.
7. Optimize infant and children case-finding approaches to ensure increased and equitable access to screening and testing as well as linkage to treatment, including preventive treatment.
8. Work with researchers and relevant experts to develop pediatric specimen banks/repositories to support faster studies of new TB diagnostics and ensure open access to academic groups and manufacturers.
9. Work with national regulatory authorities to register diagnostic assays and streamline procedures while ensuring the use of WHO approved products when considering national regulatory approval.
10. Support sharing of available diagnostic platforms and associated networks across programs to attain wider access to testing, for more optimal utilization of available platforms, more efficient systems, and improved sustainability.
11. Remove barriers to accessing screening and preventive treatment for healthy children who are exposed to TB (e.g. provide transport vouchers, home-based screening and treatment, etc.).
12. Support optimal access and supply to TB diagnostics through efficient registration of WHO recommended diagnostics and not taxing public goods.
13. Implement pre-qualification assessments of TB in vitro diagnostics to assess quality, safety and performance of specific products, as a quality assurance mechanism complementing WHO policy recommendations.
14. Streamline national regulatory approval of TB diagnostic products that have been assessed according to stringent standards for quality, safety and performance.
15. Develop and implement post market surveillance of diagnostic products
23. Jointly agree upon and execute next steps to optimize the availability and delivery of these formulations in 2019 including:
Timely and regular information sharing (including orders placed and timelines for deliveries)
Providing best possible demand forecasts
Collaborate on the optimization of limited supply within and among countries and joint prioritization among orders to ensure sustainable supplies to children once initiated
Support product uptake at country level
Regulatory filings as needed to support scale-up, timely responses to queries raised during the review, and implementation (re-validation as required) of post approval changes at risk during the review period.
50. Accelerate transition to more optimal regimens and formulations as described in WHO Guidelines and 2018 Optimal formulary by:
Developing transition plans by Q1 2019
Introducing DTG 50 mg for children above 25 kg by Q2 2019
Fully phasing out NVP based regimens by Q3 2019 in children older than 3 years and by Q2 2020 in children younger than 3 years.
Optimizing the use of LPVr solid formulations by prioritizing infants and children that most need them as well as using LPVr tablets as soon as a child can swallow them
Transitioning stable children to optimal regimens as outlined by in the WHO treatment guidelines and in the Optimal Formulary and Limited Use List
51. Increase viral load monitoring of children and ensure linkage of children failing first line drugs to 2nd and 3rd line drugs, working with donors and manufacturers to ensure availability of drugs in line with WHO guidelines.
Status: LPV/r pellets already in country and in use.
Developing transition plans by Q1 2019 / Introducing DTG 50 mg for children above 20 kg by Q2 2019: Circular issued in October 2019 for phase out of Nevirapine ART based regimen and ARV regimens for newly enrolled CALHIV which recommend DTG 50mg for those above 20kgs.
Fully phasing out NVP based regimens by Q3 2019 in children older than 3 years and by Q2 2020 in children younger than 3 years: The MOH circular issued in October 2019 provided guidance on phase out of Nevirapine, currently the transition is ongoing and there are just about 1,500 on NVP based regimens.
Optimizing the use of LPVr solid formulations by prioritizing infants and children that most need them as well as using LPVr tablets as soon as a child can swallow them: The country is using LPV/r pellets and tablets for 1 to 4 years CALHIV.
Syrup 80/20mg/ml - <6 months old children
Pellets 40/10 mg - 6 months up to 3 years and can't swallow tablets
Tablets 100/25 mg - Children able to swallow tablets
Tablets 200/50 mg - Older children able to swallow bigger sized tablets as whole
Transitioning stable children to optimal regimens as outlined by in the WHO treatment guidelines and in the Optimal Formulary and Limited Use List: This is going to be effected in the revised ARV 2020 guidelines which the program intends to release by June 2020.
Third line program for children failing PI based ARV regimens is being strengthened. The program does forecasting and Quantification for 1st, 2nd and 3rd Line ARV for CALHIV to ensure timely ARV support.
The APWG issued an updated memo on 10 January 2019 to Suppliers of paediatric LPV/r formulations, HIV program managers, and ARV logistics divisions “to provide information on global coordination efforts to ensure paediatric LPV/r formulations are appropriately distributed and utilized.” The APWG also continues to meet monthly with manufacturers and to develop a plan for increased supply by end 2019. It plans to develop a dashboard on the supply situation of LPV/r granules and pellets for the APWG website.
92. Accelerate transition to more optimal regimens and formulations as described in WHO Guidelines by:
Adopting and implementing new WHO TB guidelines relevant for children within one year of their release
Revising national procurement plans to align with WHO recommended regimens and the EML-C
Scaling-up use of dispersible fixed-dose combinations and single drug formulations for drug-sensitive and drug-resistant TB (including rifampicin + isoniazid + pyrazinamide [RHZ] and rifampicin + isoniazid [RH], INH dispersible single, ethambutol dispersible single and child-friendly second-line formulations)
Supporting the provision of shorter TB Prevention Treatment regimens for children when these regimens have appropriate data and are available in child-friendly formulations (i.e., 3RH, 3HP, 1 HP)
Strengthening reporting and recording systems for TB infection, contact tracing and provision and completion of TPT for children
Strengthening PSM systems for TPT medicines.
93. Prioritize funding for paediatric TB prevention, diagnosis (including DST), and treatment in national budgets and requests to donors, including to provide these services free of charge and to support improved models of care for children and for training of HCWs.
94. Create a plan of action to reduce stigma and discrimination in health care systems and communities and support civil society and community generated initiatives focused on pediatric TB.
95. Collect data on TB-HIV co-infection and TB treatment outcomes in children living with HIV.